Medicines and Related Substances Amendment Bill, 2008

The Treatment Action Campaign (TAC) and the AIDS Law Project (ALP) recognise the need for, and strongly support, legislative reform to ensure that the Medicines Control Council (MCC) is able effectively and efficiently to regulate medicines and other health products. This, we are told, is the ostensible purpose of the draft Medicines and Related Substances Amendment Bill, 2008 (“the draft Bill”)1.

But if the draft Bill were ever to become law, this would not be achieved. Instead, its enactment would signal the final death knell of the scientific governance of medicines and clinical trials in South Africa. In our view, this is the latest attack on the evidence-based regulation of medicines and clinical trials, which began in early 1997 when the then independent and internationally respected MCC intervened to stop unauthorised and unethical trials on the industrial solvent Virodene.

This latest development, made in the name of improving effectiveness and efficiency, seeks to destroy what to date has only been weakened. It does so by proposing an amendment to the Medicines and Related Substances Act 101 of 1965 (“the Medicines Act”) that will effectively allow the Minister of Health (“the Minister”) to block the registration of medicines of proven quality, safety and efficacy, as well as to allow the sale and provision of untested “treatments” and “cures”.

The TAC and ALP are concerned that the current Minister is pursuing a dangerous agenda that, if successful, will severely undermine the work of the next Minister, Cabinet and Parliament. With this understanding, we submit that the draft Bill is irredeemably flawed and should be withdrawn. In addition to its problematic substance, it has been developed2 – and is likely to be
processed by the Department of Health (DoH)3 – in an unaccountable and non-transparent manner that makes a mockery of public consultation.

Instead of rushing to table draft legislation in Parliament, the DoH should embark on a process of open and accountable engagement with all domestic stakeholders – and not just the pharmaceutical industry – on how and in what way the MCC’s statutory mandate can and should be amended to ensure that it is indeed in a position appropriately to regulate the development, registration and use of safe and effective medicines of good quality free from political interference.